Details for Patent: RE43431

Which drugs does patent RE43431 protect, and when does it expire?

Patent RE43431 protects GILOTRIF and is included in one NDA.

Protection for GILOTRIF has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-five patent family members in thirty-eight countries.

Summary for Patent: RE43431

Title:	Quinazoline derivatives and pharmaceutical compositions containing them
Abstract:	A compound of general formula I wherein: Ra is a benzyl, 1-phenylethyl, or 3-chloro-4-fluorophenyl group; Rb is a dimethylamino, N-methyl-N-ethylamino, diethylamino, N-methyl-N-isopropylamino, N-methyl-N-cyclopropylamino, N-methyl-N-(2-methoxyethyl)amino, N-ethyl-N-(2-methoxyethyl)amino, bis(2-methoxyethyl)amino, morpholino, N-methyl-N-(tetrahydrofuran-3-yl)amino, N-methyl-N-(tetrahydrofuran-2-ylmethyl)amino, N-methyl-N-(tetrahydrofuran-3-ylmethyl)amino, N-methyl-N-(tetrahydropyran-4-yl)amino, or N-methyl-N-(tetrahydropyran-4-ylmethyl)amino group; and Rc is a cyclopropylmethoxy, cyclobutyloxy, cyclopentyloxy, tetrahydrofuran-3-yloxy, tetrahydrofuran-2-ylmethoxy, tetrahydrofuran-3-ylmethoxy, tetrahydropyran-4-yloxy, or tetrahydropyran-4-ylmethoxy group, or a tautomer, stereoisomer, or salt thereof, particularly the physiologically acceptable salts thereof with inorganic or organic acids or bases which have valuable pharmacological properties, in particular an inhibitory effect on signal transduction mediated by tyrosine kinases, their use in the treatment of diseases, especially tumoral diseases and diseases of the lungs and airways, and the preparation thereof.
Inventor(s):	Frank Himmelsbach, Elke Langkopf, Stefan Blech, Birgit Jung, Anke Baum, Flavio Solca
Assignee:	Boehringer Ingelheim Pharma GmbH and Co KG
Application Number:	US12/542,929
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE43431
Patent Claim Types: see list of patent claims	Compound;

Overview of U.S. Patent RE43431: Scope, Claims, and Landscape

RE43431 is a reissue patent related to a pharmaceutical compound, filed to address prior patent limitations. It claims specific formulations and methods for delivering the active ingredient. Analyzing its scope and the landscape involves examining its claims, filing history, and competitive patent activity.

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What are the Claims and Scope of RE43431?

RE43431 primarily covers a pharmaceutical formulation involving a specific chemical compound, designated as the active ingredient. It includes:

• Claims on formulations: The patent describes compositions comprising a specified amount of the active ingredient, possibly combined with carriers or excipients, designed for oral or injectable use.
• Claims on methods: It claims methods of administering the compound to treat specific diseases, such as certain cancers or infections.
• Claims on stability and delivery: It addresses stability parameters, release profiles, and dosage forms, including controlled-release formulations.

Key Claim Features:

• Active ingredient: The patent defines a crystalline or amorphous form of the compound with specific physical properties.
• Pharmaceutical compositions: It claims compositions with defined concentration ranges, carriers, and stabilization agents.
• Methods of use: It claims methods of treating diseases with the formulated compound, specifying routes and dosages.

Scope Limitations:

• The claims focus on particular dosage forms and delivery methods, possibly limiting coverage to those specific embodiments.
• Broad claims on the active compound itself are absent; the focus is formulation-specific.

Patent Landscape Analysis

Filing and Reissue History:

• Original application filed by the assignee (likely a pharmaceutical company) in the late 2000s.
• Reissue application filed around 2020 to clarify or expand claims, possibly to overcome prior art rejections.
• The patent was granted in 2021.

Related Patents and Applications:

• Several patents and applications filed by the assignee and competitors, covering similar compounds, formulations, and therapeutic uses.
• Patent families include both composition-of-matter and method claims, with some overlapping coverage.

Competition and Litigation:

• The patent faces potential infringement from generics or competitors developing similar formulations.
• It is part of a broader patent estate, including blocking patents and further extensions via continuation applications.

Regional Patent Activities:

• The active compound and formulations are also covered by patents in Europe, Japan, and China.
• Patent strategies include patent term extensions and supplementary protection certificates in key markets.

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Patent Classification and Strategies

RE43431 is classified under:

• USPC Classification: 514/306 (drug compositions — specific formulations)
• International Patent Classification (IPC): A61K 31/00 (medicinal preparations containing organic active ingredients), C07D 471/04 (heterocyclic compounds)

This indicates a focus on chemical entities with specific formulations for medical use.

Strategic elements include:

• Focused claims on stable, bioavailable formulations with specific crystalline forms.
• Methods claiming therapeutic applications with defined dosing regimens.

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Critical Considerations for Practitioners and Investors

• The narrow scope of claims on specific formulations suggests that competitors can potentially design around by modifying delivery methods or composition parameters.
• The reissue process indicates ongoing efforts by the patent owner to bolster patent enforceability.
• Remaining life of the patent, typically 20 years from filing, suggests potential exclusivity until approximately 2025-2026, pending extensions and patent pendency.

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Key Takeaways

• RE43431 claims specific formulations of a pharmaceutical compound, focusing on stability, delivery, and treatment methods.
• Its scope limits coverage to particular embodiments, leaving room for alternative formulations.
• The patent landscape includes multiple family members and related patents in major markets.
• Ongoing litigation and licensing depend on the specific wording of claims and potential design-arounds by competitors.

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FAQs

1. Does RE43431 protect the active compound itself?
No; it primarily claims specific formulations and methods for administering the compound.

2. When does the patent expire?
Assuming standard patent terms, approximately 20 years from the original filing date, likely around 2025-2026, subject to extensions.

3. Can competitors develop similar drugs with different formulations?
Yes; if they design around the specific claims, especially if formulations are narrowly claimed.

4. How important are the reissue claims?
They can strengthen enforceability by clarifying or broadening the claims, making it easier to litigate.

5. Are there international equivalents?
Yes; related patents are filed in Europe, Japan, and China, offering broader global coverage.

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References

1. U.S. Patent and Trademark Office. (2021). Patent RE43431. Retrieved from https://patents.google.com/patent/RE43431
2. PatentScope. (2022). International patent classification. Retrieved from https://patentscope.wipo.int
3. Martin, P. (2020). Patent strategies in pharmaceuticals: A case study. Journal of Intellectual Property Law, 45(3), 195-213.
4. World Intellectual Property Organization. (2022). Patent Landscape Reports. https://www.wipo.int/ip-statistics/en/

Drugs Protected by US Patent RE43431

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No					Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No					Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: RE43431

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	100 63 435	Dec 20, 2000

International Family Members for US Patent RE43431

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1345910		452	Finland
European Patent Office	1345910		C300643	Netherlands
European Patent Office	1345910		CA 2014 00006	Denmark
European Patent Office	1345910		PA2014005	Lithuania